Implantable Artificial Bronchus And Use Of An Implantable Artificial Bronchus

ABSTRACT

An implantable artificial bronchus (IAB) is provided that is used for the treatment of chronic obstructive pulmonary diseases, such as pulmonary emphysema. The implantable artificial bronchus can be made with silicone or nitinol, and has a tapered cylindrical shape. Additional embodiments of this apparatus may be further associated with a one-way valve on the nozzle of the IAB.

FIELD OF THE INVENTION

The instant patent of invention relates to artificial bronchi for thetreatment of pulmonary emphysema, and may be associated with a one-wayvalve.

BACKGROUND OF THE INVENTION

Pulmonary emphysema is a type of chronic obstructive pulmonary disease(COPD), which is characterized by the permanent enlargement of the gasexchange units (acini) associated with the destruction of alveolarwalls, without fibrosis.

The destruction of these alveolar walls shows distinct patterns in eachperson, with different distribution and intensity. This gradual andirreversible rupture of lung tissue leads to the loss of the elasticcapacity of lung recoil, namely, the loss of the ability to expelinspired air. As a result, there is a structural derangement of the ribcage, increase of the thorax diameters and diaphragm rectification (airentrapment and hyperinflation).

Areas affected by the disease fill the thoracic cavity, leaving lessvolume available for the healthy areas of lung tissue perform hematosis.The loss of respiratory capacity leads to a progressive functionaldisability of individuals with the disease.

Although there is no cure for pulmonary emphysema, there are some formsof treatment, including medicines, muscle training and oxygen therapy.For some more severe cases, a lung volume reduction surgery or lungtransplantation may be indicated. While the medicines and muscletraining have limited results, the lung volume reduction surgery andlung transplantation are very traumatic, and a very limited number ofpatients can be submitted to these treatments.

Since the year 2000, several less traumatic alternatives have beenproposed to alleviate the suffering of patients with pulmonaryemphysema.

a) Methods based on forced scarring of the sick tissue using chemicalsor steam to produce mechanical retraction. These techniques are stillbeing assessed and have the risk of producing or accelerating the damagecaused by the disease itself after an initial improvement.

b) The European patent EP1524942 describes a self-expanding nitinolendobronchial valve covered by a silicone membrane, which has astructure that allows unidirectional air flow. This valve is implantedin areas close to the affected regions, causing the air accumulatedtherein to be expelled. Due to its unidirectional characteristic, itdoes not allow the reentry of air into the affected areas. The problemof this technique is the collateral communication between the entrappedair in the treated area and the remaining parts of the same lung.Another problem is that the working tissue should be excluded, for thereto be a beneficial effect.

c) An alternative approach was the creation of ancillary air passages inthe bronchi wall, to allow lung emptying. Although this alternativepresents a more efficient solution over the affected lung, the existingstate of the art results demonstrated the premature closure of thesepassages.

d) There is also treatment with mechanical retraction of the airways,where nitinol spirals (nickel-titanium alloy) are implanted using astraightened bronchoscope and, after the implant, the covers that keepthe spiral straightened are removed, causing it to return to itsoriginal conformation, thus performing the retraction of the pulmonaryparenchyma. This method is limited due to its irreversibility, inabilityof using an anticoagulant medication (for circulatory illnesses), a veryhigh risk in patients with high pulmonary arterial pressure and lack ofeffect on patients affected with an advanced form of the disease, whenthere is not almost lung parenchyma.

Thus, there is the need for an alternative, a procedure that is notaggressive to the lung and that promotes lung disinsufflation withoutexcluding its healthy areas.

BRIEF DESCRIPTION OF THE FIGURES

FIGS. 1 and 2 respectively represent the front and side views of anembodiment of the implantable artificial bronchus (1), according to thisinvention.

FIGS. 3 and 4 respectively represent upper and lower profile views ofthe implantable artificial bronchus (1).

FIG. 5 shows the upper view of the implantable artificial bronchus (1).

FIG. 6 represents a lung showing the branches of the airway. The arrowsrepresent compression that the air exerted on the same.

FIG. 7 shows the use of an implanted embodiment of implantableartificial bronchus, according to the present invention.

FIG. 8 represents another embodiment of the implantable artificialbronchus, made with a nitinol web.

FIG. 9 represents the use of another embodiment of the implantableartificial bronchus.

DESCRIPTION OF THE INVENTION

In order to meet the need for an effective form of treatment, which isnot an aggressive or an invasive procedure for the body, an implantableartificial bronchus (IAB) was developed.

The IAB, according to the present invention, consists of a taperedcylindrical body, where the upper nozzle is greater than the loweropening, comprising openings along its length and side wings.

In this invention, openings are any kind of side perforation or leakagefrom a network assembly.

The IAB (1) can be built in two alternative forms, with a silicone body(SB) or a nitinol web body (NWB), wherein both comprise in the body (2)a nozzle (3) and side wings (4), with side openings (5), upper (6) andlower (7) which enable the peripheral range for promoting lungdeflation, which may have various longitudinal lengths.

In the SB assembly, the side wings are used for fixing the same in theair way/lung parenchyma, and in the NWB assembly, they enable a betterhandling, in case of IAB withdrawal.

The NWB embodiment further has silicone or fluoropolymer likepolytetrafluoroethylene rings (8) and longitudinal rods (9), of siliconeor fluoropolymer like polytetrafluoroethylene, and these structuresprevent the incorporation of the nitinol web by the lung wall, and alsopreserves the possibility of IAB withdrawal in case of rejection or needto reimplant.

Another embodiment of this invention is the association of IAB with aone-way valve, as described in EP1524942—of H. Michael to EmphasysMedical Inc., published on Apr. 27, 2005, incorporated herein byreference. This association prevents lung parenchyma against injuriescaused by dry air and moisture reduction, thus avoiding tissue reactionand closure by healing of those openings.

The IAB (1) features a (proximal) upper opening (6) which allows theassociation with the one-way valve, and also its maintenance, since itallows the removal of the valve, device cleaning with broncoscope andvalve reimplantation.

The use of this device is made by bronchoscopy. Initially, it isnecessary to identify the locations where it is desired to carry out theapplication, through an image study obtained by computed tomography ofthe thorax, associated or not to a three-dimensional reconstructionprogram.

After identifying the positions, the application can be performed in twoways, one for IAB with SB, which begins with the passage of the needlefor piercing the bronchial wall and introducing the guide wire in thelung parenchyma, and optionally, the balloon dilator can be passed.

The implanting of IAB with NWB does not require perforations into thelung wall. The implant path is initially identified with a malleablemetal guide. A subsequent catheter passage can be done to guide thecompressed IAB or the compressed IAB can be introduced directly byguidewire. After withdrawing the catheter, the IAB naturally expands andremain on the airway, promoting the enlargement of this path andproviding causing lung deflation.

The present invention avoids the state of the art problems, since itscylindrical body allows the implantation without the need for extensivecuts or openings that trigger healing processes, or along the airways.Moreover, in the second embodiment according to the present invention,there is no need for any perforation except eventually for very distalairway. Additionally, its conformation with decreasing radius along thebody, with side openings, promotes swirling of the air which enters theIAB. Thus, there is no sudden entry and the air is dispersed moreevenly, thus ensuring an efficient and safe distribution, withoutcausing tissue healing.

The use of IAB provides more safety and effectiveness in the treatmentof lung emphysema, since it allows the air exit, does not trigger thehealing mechanisms and does not destroy or annul the normal lung tissue.

It shall be understood that the embodiments described above are merelyillustrative and any modification to them may occur for a person skilledin the art. Therefore, the present invention should not be considered asbeing limited to the embodiments described in this document.

The person skilled in the art will be able to readily evaluate, by meansof the teachings contained in the text and in the presented examples,advantages of the invention, and to propose modifications and equivalentalternatives to the embodiments, without departing from the scope of theinvention, as defined in the attached claims.

1. An implantable artificial bronchus, comprising: a tapered cylindricalbody; a nozzle; side wings; side openings, and upper and lower openings.2. The implantable artificial bronchus, according to claim 1, whereinthe body is made with silicone, and include the side wings forattachment, and wherein the side openings are perforations along thebody.
 3. The implantable artificial bronchus, according to claim 1,wherein the body is made with nitinol web, and include wings for betterhandling, and wherein the openings consist of leaks from the networkassembly.
 4. The implantable artificial bronchus, according to claim 3,further comprising silicone or fluoropolymer likepolytetrafluoroethylene rings and silicon or fluoropolymer likepolytetrafluoroethylene rod.
 5. The implantable artificial bronchus,according to claim 1, wherein the implantable artificial bronchus isassociated with a one-way valve.
 6. The implantable artificial bronchus,according to claim 1 for treating chronic obstructive pulmonarydiseases.